Regulatory Affairs Specialist
- Onsite
- Full Time
- Product & Technology
About the role
Overview: Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company.
We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models.
Responsibilities
- Plan, establish, implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with EN ISO 13485 and applicable medical device regulatory requirements.
- Drive QMS streamlining and process improvements across functions to ensure effective, efficient, and compliant quality processes throughout the product lifecycle.
- Develop, review, and maintain quality policies, procedures, SOPs, work instructions, forms, and quality records in alignment with regulatory and organizational requirements.
- Ensure effective implementation and maintenance of Design Controls, Document Control, Change Control, Risk Management, CAPA, Non-Conformance, Complaint Handling, Supplier Quality, Training, and other QMS processes.
- Support regulatory compliance with applicable standards and regulations, including US FDA, EU MDR/CE Marking, CDSCO, IEC 60601, IEC 62304, ISO 14971, and other relevant requirements.
- Prepare and maintain regulatory dossiers, Device Master Files/Technical Documentation, and quality-related documentation required for regulatory submissions and product lifecycle activities.
- Work closely with Product Development, Product Transfer, Manufacturing, Engineering, and other cross-functional teams to ensure QMS and regulatory requirements are effectively implemented.
- Provide guidance to cross-functional teams on quality and regulatory requirements at various stages of the medical device product lifecycle.
- Conduct or support internal audits, supplier audits, Notified Body audits, and regulatory inspections, including audit preparation, coordination, response, and closure of observations/findings.
- Lead the identification, investigation, implementation, and effectiveness verification of CAPAs and corrective/preventive actions.
- Coordinate Management Review meetings, including preparation of quality metrics, performance indicators, inputs, action items, and follow-up activities.
- Establish and monitor quality objectives, KPIs, and quality metrics to evaluate QMS effectiveness and identify opportunities for improvement.
- Support supplier qualification, evaluation, monitoring, and supplier audits in accordance with established quality procedures.
- Drive compliance with Good Documentation Practices (GDP) and ensure appropriate control, traceability, accuracy, and integrity of quality records.
- Develop and deliver QMS and regulatory training and ensure employee awareness and compliance with applicable company policies, procedures, standards, and regulatory requirements.
- Monitor changes in medical device regulations, standards, and regulatory guidance and assess their impact on the organization's QMS and products.
- Support regulatory compliance assessments and gap assessments and coordinate implementation of required actions.
- Ensure effective implementation of QMS processes, regulatory requirements, and quality commitments across the organization.
- Identify opportunities for continuous improvement, process optimization, and QMS maturity enhancement through data-driven analysis, audit findings, CAPA trends, and management review outputs.
- Maintain readiness for regulatory inspections and third-party audits and support timely and effective closure of audit observations.
- Provide subject-matter expertise and guidance on QMS, quality assurance, regulatory compliance, and applicable medical device standards.
Requirements
- B.Tech or equivalent educational qualification.
- 3-5 years of experience in Medical Device Quality Assurance, Quality Management Systems, and/or Regulatory Affairs.
- Hands-on or working knowledge of QMS implementation, streamlining, improvement, maintenance, and compliance in accordance with ISO 13485.
- Experience in developing, implementing, reviewing, and maintaining QMS procedures, SOPs, work instructions, and quality records.
- Working knowledge of Design Controls, CAPA, Change Control, Document Control, Non-Conformance, Risk Management, Supplier Quality, Training, Complaint Handling, and other core QMS processes.
- Knowledge of US FDA, EU MDR/CE Marking, CDSCO, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable medical device regulations and standards.
- Experience supporting regulatory submissions, new medical device registrations, and maintenance of regulatory/technical documentation.
- Experience supporting regulatory inspections, Notified Body audits, internal audits, and supplier audits, including preparation and closure of findings.
- Ability to analyze and interpret regulations, standards, guidance documents, technical procedures, and regulatory requirements and translate them into practical QMS processes.
- Experience in quality metrics, Management Review, CAPA effectiveness, audit readiness, and continuous improvement initiatives.
- Working knowledge of Good Documentation Practices and quality documentation management.
- Ability to collaborate effectively with cross-functional teams throughout the medical device product development and product transfer lifecycle.
- Strong analytical, organizational, problem-solving, and process-improvement skills.
- Ability to work independently while effectively collaborating with different departments and stakeholders.
- Strong leadership, communication, interpersonal, project management, and time-management skills.
- Highly organized, process-oriented, detail-oriented, and committed to maintaining quality, compliance, and continuous improvement.
Description as published by Dozee.
